Sleep Aid Maximum Strength

Sleep Aid Maximum Strength is an FDA drug label for the active ingredient DIPHENHYDRAMINE HCL manufactured by P & L Development, LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231023.

Generic: DIPHENHYDRAMINE HCL

Manufacturer: P & L Development, LLC

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 59726-760

Application: M012

Effective: 20231023

Active Ingredients: Active ingredient (in each softgel) Diphenhydramine HCl 50 mg Purpose Nighttime sleep-aid

Indications & Usage

Use For relief of occasional sleeplessness.

Dosage & Administration

Directions adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Contraindications

Not available.

Warnings

Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic drinks. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Adverse Reactions

Not available.

More from same ingredient

Allergy

Allegiant Health

Banophen

Proficient Rx LP

Nighttime Sleep-Aid

VALU MERCHANDISERS COMPANY

Sleep Aid

Allegiant Health

Sleep Aid

Allegiant Health

nighttime sleep-aid

Bionpharma Inc.